Could a Two-Drug cocktail tame ALS? early trial hints at hope

NCT ID NCT06307301

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested whether combining two drugs—abatacept and interleukin-2—is safe for people with ALS. The goal was to boost the body's regulatory T cells, which may help slow disease progression. Only 5 participants were enrolled, and the study focused on safety and immune system changes, not on curing the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abatacept (Orencia) and interleukin-2 (aldesleukin)
What this could lead to
If safe and effective, this combination could help slow ALS progression by boosting the body's own immune regulation.
What could go wrong
This is a very early, small phase 1 trial with only 5 participants, so results may not apply to all ALS patients. Side effects from the drugs are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

5 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients will be eligible for initial enrollment on this study if they meet the following criteria at the time of screening: 1. Provided informed consent and authorized use of protected health information (PHI) in accordance with national and local patient privacy regulations. 2. ALS meeting El Escorial criteria for possible, probable, lab-supported probable, or definite ALS. 3. At least 18 years old. 4. Total bilirubin less than or equal to 1.5 mg/dL 5. Alanine aminotransferase level (ALT) less than or equal to five times normal, albumin greater than or equal to 3.0 gm/dL 6. Serum creatinine less than 1.5 mg/dL 7. Capable of complying with all study procedures, including the study drug delivery procedure, in the Investigator's opinion. 8. A family member or caretaker who is expected to be consistently available to administer both study drugs of abatacept and IL-2 if the participant is unable to do so. 9. On a stable regimen of riluzole for at least 30 days at the time of screening. If not on riluzole at the time of study entry, willing to refrain from initiation of the agent for the duration of the trial. 10. Patients on edaravone willing to refrain from taking edaravone on the same day as they will receive the abatacept injection for the duration of the trial. If not on edaravone at the time of study entry, willing to refrain from initiation of the agent for the duration of the trial. 11. Forced vital capacity (FVC) ≥50% of predicted capacity for age, height, and sex at screening, or receiving treatment with noninvasive ventilation if FVC \< 50% of predicted for age, height, and sex at screening. Exclusion Criteria: Patients will be ineligible to participate if any of the following are true at the time of screening: 1. Serious, active bacterial, fungal, or viral infection, active or latent tuberculosis. 2. Tracheostomy. 3. Severe cardiac dysfunction defined as left ventricular ejection fraction \<40% if an echocardiogram is medically indicated to clarify ongoing symptoms or EKG findings.; a history of non-controlled cardiac arrhythmias; history of cardiac tamponade; Unstable angina or MI in the last 3 months. 4. Hypersensitivity or allergy to IL-2 or abatacept. 5. History of bowel ischemia/perforation, or GI bleeding requiring surgery. 6. History of resistant seizures, history of coma or toxic psychosis lasting \>48 hours. 7. Platelets \<100,000/mm3; hematocrit \<30%. 8. History of cancer in the past 5 years (except cutaneous Basal cell carcinoma or squamous cell carcinoma). 9. Hx of immunomodulation therapy including IL-2 or abatacept administration in the past 90 days. 10. Treatment with another investigational drug, biological agent, or device within 30 days or 5 half-lives of screening, whichever is longer. 11. If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or unwilling to use effective contraception for the duration of the trial and for 90 days after treatment. 12. If male of reproductive capacity, unwilling to use effective contraception for the duration of the trial and for 90 days after treatment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

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